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by Mark S. Senak
Eye On FDA



This week the FDA has announced a new initiative on Food Safety. There has been a lot of activity in this area of recent months.

Perhaps more than pharmaceutical concerns, there have been a number of food scares during the past year - spinach, lettuce, China and melamine, China and toothpaste, China and fish, the FDA announcing the approval of the concept of cloned food... you get the idea.

The new initiative announced is designed to be "a national program to bring about the adoption of more uniform, equivalent, and high quality regulatory programs by state agencies responsible for regulating facilities that manufacture, process, pack, or hold food under FDA’s jurisdiction." Actually more about this in the Weekly Roundup tomorrow.

This comes on the heels of naming David Acheson as Food Safety Czar, who interestingly enough, was not quoted or mentioned in the FDA Press Release on the new food safety initiative though i guess his position has more to do with food defense than food safety though I hope to get to talk to him at some point about that for a podcast.

But that is neither here nor there. The point I want to make is this. The PDUFA legislation has been reported to be put off until September (no sense in getting done today what can be done tomorrow...). But eventually the PDUFA bill will go forward and in it, there will be several FDA reforms aimed at improving the way the FDA approaches drug safety.

Think about it. I hate to be cynical, but surely the lions in Congress who have been on the back of the FDA aren't going to continue to harp on drugs when they've gone through all the trouble to pass legislation that fixes all of the perceived problems. That would mean that their legislation was ineffectual. Instead, if there is a desire to keep on the back of the FDA, that can mean only one thing - food is the target.

So here, at last, is my point. With drug safety out of the way of Congress with the passage of PDUFA, look for next year - an election year by the way, in case you haven't noticed, to be focused less on drug safety and more on food safety. The same hearings we are seeing today regarding drug specific products may be held next year, only this time about various aspects of food safety - quite possibly ranging from handling of food, to importation of food, to labeling of food, to obesity issues to botulism to adulteration... etc.

By the way, there hasn't been a meeting of the Food Advisory Committee since July, 2005...

In other words, next year, look for food to take some heat.




Eye On FDA is a regular contributor to BioHealth Investor
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